Gaspardone Carlo, Trabattoni Daniela, d'Atri Daniele O, Morosato Michele, Costa Paolo, Fraccaro Chiara, Donti Andrea, Saia Francesco, Toscano Evelina, Scalise Filippo, Cucco Alessio, Patti Giuseppe, Nerla Roberto, Castriota Fausto, Trani Carlo, Improta Riccardo, Mancone Massimo, Sardella Gennaro, Musto Carmine, Paciaroni Maurizio, Morciano Davide A, Ricchetti Gianluca, Zaccaria Lorenzo, Beneduce Alessandro, Barone Giuseppe, Salerno Anna, Vella Ciro S, Montorfano Matteo, Pappone Carlo, Colombo Antonio, Maisano Francesco, Burzotta Francesco, Tarantini Giuseppe, Margonato Alberto, Gaspardone Achille, Godino Cosmo
Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
IRCCS Centro Cardiologico Monzino, Milan, Italy.
JACC Cardiovasc Interv. 2025 Jun 23;18(12):1526-1537. doi: 10.1016/j.jcin.2025.04.041.
Transcatheter patent foramen ovale (PFO) closure has become the gold-standard treatment for patients with cryptogenic embolism and PFO, but long-term outcomes data are limited.
The aim of this study was to report the extended clinical outcomes of patients who underwent transcatheter PFO closure for cryptogenic embolism.
PROLONG (PFO Transcatheter Occlusion Long-Term Outcomes National Group) is an investigator-initiated, multicenter, retrospective registry that enrolled patients who underwent transcatheter PFO closure between 1999 and 2013 at 12 centers in Italy. This analysis included only patients who underwent PFO closure for cryptogenic embolism, defined as cryptogenic ischemic stroke, transient ischemic attack, systemic embolism, or silent ischemic lesions on magnetic resonance imaging. Clinical, imaging, procedural, and follow-up data were collected from electronic health records and telephone interviews.
The study included 1,245 patients (mean age 47 ± 12 years, 56% women), with a mean follow-up duration of 14.5 ± 2.4 years. During follow-up, 34 patients (2.7%) experienced recurrent ischemic stroke, transient ischemic attack, or systemic embolism (0.19 per 100 patient-years). Predictors of recurrent events were Risk of Paradoxical Embolism (RoPE) score ≤ 7 (HR: 3.44; 95% CI: 1.06-11.3; P = 0.041), nonprobable PFO-Associated Stroke Causal Likelihood (PASCAL) classification (HR: 2.72; 95% CI: 1.17-6.34; P = 0.020), and new-onset atrial fibrillation (HR: 7.01; 95% CI: 2.45-20.1; P < 0.001). Serious complications were rare (0.4% in hospital, 0.4% during follow-up) and nonfatal.
This study confirms the long-term efficacy and safety of transcatheter PFO closure for patients with cryptogenic embolism and PFO in a real-world setting. (PFO Transcatheter Occlusion Long-Term Outcomes National Group [PROLONG] Registry; NCT06504121).
经导管卵圆孔未闭（PFO）封堵术已成为不明原因栓塞合并PFO患者的金标准治疗方法，但长期预后数据有限。
本研究旨在报告因不明原因栓塞接受经导管PFO封堵术患者的长期临床结局。
Prolong（PFO经导管封堵长期结局全国研究组）是一项由研究者发起的多中心回顾性注册研究，纳入了1999年至2013年间在意大利12个中心接受经导管PFO封堵术的患者。本分析仅纳入因不明原因栓塞接受PFO封堵术的患者，不明原因栓塞定义为不明原因缺血性卒中、短暂性脑缺血发作、全身性栓塞或磁共振成像上的无症状缺血性病变。从电子健康记录和电话访谈中收集临床、影像、手术和随访数据。
该研究纳入了1245例患者（平均年龄47±12岁，56%为女性），平均随访时间为14.5±2.4年。随访期间，34例患者（2.7%）发生复发性缺血性卒中、短暂性脑缺血发作或全身性栓塞（每100患者年0.19例）。复发事件的预测因素为反常栓塞风险（RoPE）评分≤7（HR：3.44；95%CI：1.06-11.3；P=0.041）、不太可能的PFO相关卒中因果可能性（PASCAL）分类（HR：2.72；95%CI：1.17-6.34；P=0.020）和新发房颤（HR：7.01；95%CI：2.45-20.1；P<0.001）。严重并发症罕见（住院期间0.4%，随访期间0.4%）且非致命。
本研究证实了在现实世界中，经导管PFO封堵术治疗不明原因栓塞合并PFO患者的长期疗效和安全性。（PFO经导管封堵长期结局全国研究组[Prolong]注册研究；NCT06504121）
